INVESTIGATOR SELF-ASSESSMENT CHECKLIST

Social and Behavioral Sciences

The purpose of the Investigator Self-Assessment Checklist is to determine that research is being conducted properly with adherence to Federal Regulations (45 CFR 46) and University of Utah IRB Policy for the protection of human participants. An IRB Administrator will be available to assist you and answer any questions you may have.
This Self-Assessment is separated into sections appropriate for social and behavioral science studies. Some sections may not be applicable to all studies.

GENERAL INFORMATION

Principal Investigator:

Campus address/phone#:
Co-Investigator(s):
E-mail address/phone#:
Study Coordinator(s)
E-mail address/phone#:

Study Staff changes since last continuing review?

/ YesNo

If yes, was amendment submitted to IRB?

/ YesNo N/A

Name of person completing this checklist

IRB Protocol Number /

Study Title

Institution/Department

/ U of Utah Health Sciences U of Utah Main Campus
VAMC PCMC Shriners
Date checklist completed
Sponsor/Name: / Industry Government Internal/Department
Foundation Other:
Date of IRB Initial Approval:
Total # Enrollment at this site / #Approved: #Enrolled to date:

REGULATORY DOCUMENTATION

Every research study should maintain regulatory documentation on file in order to verify that regulatory requirements to conduct research are met. Some studies require different regulatory documents, depending on the type of study and sponsor. Review your regulatory documents and complete this section according to the requirements that apply to your study.

Some studies may choose to maintain regulatory documentation electronically or on paper. In either case, documentation should be organized and accessible in such a way that an outside auditor could view and assess the documentation easily and securely without violating University or sponsor privacy, confidentiality, and data access requirements.

Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. Is the approved protocol on file? (Original and all previously approved versions)
/ Yes
No
N/A
  1. Are copies of CVs/resumes/licenses/certificates for the PI, Co-PI, faculty sponsor, and study staff on file? (updated within the past two years)
/ Yes
No
N/A
  1. Are they signed and dated or labeled with a version date?
/ Yes
No
N/A
  1. Is there a participant enrollment log or spreadsheet?
See the Participant Selection Criteria section for more details regarding this requirement. / Yes
No
N/A
  1. Is the participant enrollment log complete and up-to-date?
/ Yes
No
N/A
  1. Is there a data monitoring log?
See the Data Monitoring section for more details regarding this requirement. / Yes
No
N/A
  1. Is the data monitoring log complete?
/ Yes
No
N/A
  1. Is there a staff signature and delegation of responsibilities log?See the Delegation of Responsibilities section for more details regarding this requirement.
/ Yes
No
N/A
  1. Is the staff signature and delegation log complete and up-to-date?
/ Yes
No
N/A
  1. Is the grant application on file?
/ Yes
No
N/A
  1. Is all correspondence to and from the sponsor on file?
/ Yes
No
N/A
  1. Are copies of training completion certificates for the PI, Co-PI, and study staff on file? (human participant research training, study specific training, HIPAA training, etc.)
/ Yes
No
N/A
  1. Is there a staff training log?
/ Yes
No
N/A
  1. Is the staff training log complete and up-to-date?
/ Yes
No
N/A

IRB DOCUMENTATION

Every research study should maintain IRB documentation on file in order to verify that IRB requirements to conduct research are met. Some studies require different IRB documents, depending on the type of study and sponsor. Review your IRB documents and complete this section according to the requirements that apply to your study.

Some studies may choose to maintain IRB documentation electronically or on paper. In either case, documentation should be organized and accessible in such a way that an outside auditor could view and assess the documentation easily and securely without violating University or sponsor privacy, confidentiality, and data access requirements.

Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. Is all correspondence to and from the IRB on file? (emails, submissions/applications, approval letters, revision letters, expiration notices, etc.)
/ Yes
No
N/A
  1. List the continuing reviews by approval date that have occurred since study initiation.
/ LIST:
  1. Is each IRB approved continuing review application and related correspondence on file?
/ Yes
No
N/A
  1. Was each continuing review application submitted on time (between 45-60 days of expiration)?
/ Yes
No
N/A
  1. Was there any lapsed period(s) between approval date and expiration date?
/ Yes
No
N/A
  1. If yes, was any participant enrolled or did any other study procedures occur during this lapsed period?
/ Yes
No
N/A
  1. If yes, was a deviation report form submitted to the IRB?
/ Yes
No
N/A
  1. List the amendments by approval date and amendment title that have been submitted since study initiation. Include amendments that were submitted with continuing review applications.
/ LIST:
  1. Is each IRB approved amendment application and related correspondence on file?
/ Yes
No
N/A
  1. Were any changes to the study initiated prior to IRB approval of an amendment?
/ Yes
No
N/A
  1. If yes, was a deviation report form submitted to the IRB?
/ Yes
No
N/A

UNANTICIPATED PROBLEM & DEVIATION REPORTING

The University of Utah IRB requires researchers to submit reports on events that may represent unanticipated problems involving risks to participants and others (UPs) including unexpected, related adverse events. Researchers are required to submit the report form as soon as possible after the PI learns of the event, but in all cases within 10 working days.

UPs are defined as any incident, experience or outcome that meets all of the following criteria:

  • Unforeseen (not expected by the researcher or the research participant) given the research procedures and the participant population being studied; and
  • Related or probably related to participation in the research or if the event or problem probably or definitely affects the safety, rights and welfare of current participants; and
  • Suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.

For more information regarding this policy, visit the IRB website at

Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. List the report forms by submission date, report form title, and IRB determination that have been submitted since study initiation.
/ LIST:
None
  1. Is each report form and related correspondence on file?
/ Yes
No
N/A
  1. Did any of the report forms require corrective or preventive actions to be completed?
/ Yes
No
N/A
  1. If yes, were the corrective and preventive actions completed?
/ Yes
No
N/A
  1. Have there been any problems or events that should have been reported promptly to the IRB that were not reported?
/ Yes
No
N/A
  1. If yes, what is the reason that a report form was not promptly submitted?

  1. Is there documentation that the PI has evaluated all problems and events for this study to determine the need to report them promptly?
/ Yes
No
N/A

PARTICIPANT RECRUITMENT PROCEDURES

Recruitment methods, including advertisements, must not interfere with the equitable selection of participants and must adhere to IRB policy. Additionally, the IRB considers recruitment to represent a part of the consent process, and thus recruitment must not violate the regulatory requirements of informed consent.

For more information about the IRB policy for “Recruitment Methods & Advertisements”, visit the IRB website at

Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. Are recruitment methods described in the protocol and/or IRB application?
/ Yes
No
N/A
  1. How are potential participants identified? Check all that apply.
/ Record Review
In person
Database
Recruitment materials (flyers, recruitment letters, etc.)
Other:
N/A
  1. Who makes initial contact with potential participants? Check all that apply.
/ PI
Co-Investigator
Study Staff
Other:
N/A
  1. How is initial contact made? Check all that apply.
/ Phone call
In person
Letter/Email
Other:
N/A
  1. If recruitment materials are used, specify. Check all that apply.
/ Media advertisements
Flyers
Websites or web postings
Letters/Emails
Other:
N/A
  1. Have all recruitment materials been approved by the IRB?
/ Yes
No
N/A
  1. Are all approved recruitment materials on file? (Original and all previously approved versions)
/ Yes
No
N/A

PARTICIPANT SELECTION CRITERIA

Appropriate inclusion and exclusion criteria for research participants are essential in order to ethically justify human subject research. Inclusion and exclusion criteria should be clearly stated and reasonable. Poorly specified inclusion/exclusion criteria may result in inadvertent exclusion of eligible research subjects and an imbalance of or inappropriate enrollment of research subjects.

Randomly choose 5 participant files for inspection. Review the study files for the participants you have chosen for inspection and complete the following.

Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. Is there a method of documenting that participants meet inclusion/exclusion criteria?
/ Yes
No
N/A
  1. Was the participant included/excluded appropriately?Answer for each participant below.

Participant #1: / Yes
No
N/A
Participant #2: / Yes
No
N/A
Participant #3: / Yes
No
N/A
Participant #4: / Yes
No
N/A
Participant #5: / Yes
No
N/A
  1. If ‘No’ for any participant, was a deviation report form submitted to the IRB?
/ Yes
No
N/A
  1. Is there documentation of who (name and date) verified each participant’s eligibility for inclusion in the study?
/ Yes
No
N/A

INFORMED CONSENT

Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research participant. Persons obtaining consent from participants must be qualified and trained to conduct this process. The informed consent process may involve the following types of documents:

  • Adult informed consent document
  • Parental permission document
  • Assent document
  • Consent cover letter
  • Consent script

Part I

Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. List the versions*of the consent/parental permission/assent document(s) are there since the beginning of the study. Provide the approval and expiration date for each version of the document(s).
/ LIST:
  1. Are all original copies of the IRB approved documents on file?
/ Yes
No
N/A

* Every consent form approved since the original submission results in a new version. Version does not refer to the number of consent forms being used at a given time, such as a consent form for each type of study population (e.g. healthy volunteers, adult participants, minors).

Part II

Randomly choose 5 participant files for inspection. Using these participants files, complete the information below.

Participant study number: / Type of Document Used / Participant / Parent / LAR
signed / Date signed / Person Obtaining Consent signed / Date signed / If a waiver of documentation of consent was used (no participant signatures obtained), describe how you documented consent for the participant:
Participant #1: / Y / N / Y / N
Participant #2: / Y / N / Y / N
Participant #3: / Y / N / Y / N
Participant #4: / Y / N / Y / N
Participant #5: / Y / N / Y / N
Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. Were any expired, non-approved, or invalid consent documents used?
/ Yes
No
N/A
  1. If yes, was a deviation report submitted to the IRB?
/ Yes
No
N/A
  1. Did each participant receive a copy of the signed consent document (or of the un-signed consent document if a waiver of documentation of consent was used)?
/ Yes
No
N/A
  1. Is there documentation in the study record that the participants received a copy of the consent?
/ Yes
No
N/A
  1. Is there documentation that a consent process occurred with each participant and that questions were answered before signing the consent or agreeing to participate?
/ Yes
No
N/A

SOURCE DOCUMENTATION & DATA MANAGEMENT

Source documentation is considered the first or original recording of any observation made or data generated about a participant while that person is enrolled in a study. The recording of source information can occur on any medium and anyone interacting with the participant while in the study can generate a source document. For example, a source document could be a health record, a questionnaire or survey, an audio or video recording, etc.

Research data is often transcribed from a source document intoanother format, such as a data collection worksheet, a spreadsheet, a database, or a written transcript of audio files, for data management and analysis. Occasionally, transcription of source documentation into research data is not necessary, as the source document is acting as the research record directly.

Randomly choose 5 participant files for inspection. Using these participants files complete the information below.

Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. Is there complete source documentation for each participant?
/ Yes
No
N/A
  1. Has the research data been completely transcribed from the source documentation? Answer for each participant below.

Participant #1: / Yes
No
N/A
Participant #2: / Yes
No
N/A
Participant #3: / Yes
No
N/A
Participant #4: / Yes
No
N/A
Participant #5: / Yes
No
N/A
  1. Has the research data been accurately transcribed from the source documentation? Answer for each participant below.

Participant #1: / Yes
No
N/A
Participant #2: / Yes
No
N/A
Participant #3: / Yes
No
N/A
Participant #4: / Yes
No
N/A
Participant #5: / Yes
No
N/A
  1. If errors in the data were identified, is there documentation of who identified the error and if/how it should be corrected?
/ Yes
No
N/A

DATA MONITORING

For more information about data monitoring, visit the IRB website at for the following topics:

  • Data and Safety Monitoring
  • Privacy and Confidentiality in Research
  • HIPAA Privacy Rule and Authorization
  • Audio/Multimedia Recordings
  • Certificates of Confidentiality

Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. Are privacy and confidentiality protections described in the protocol and/or IRB application?
/ Yes
No
N/A
  1. Have any deviations from the privacy and confidentiality protections occurred?
/ Yes
No
N/A
  1. Have any confirmed breaches of privacy or confidentiality occurred?
/ Yes
No
N/A
  1. If yes, was the breach reported to the IRB via the report form?
/ Yes
No
N/A
  1. Is a data monitoring plan described in the protocol and/or IRB application?
/ Yes
No
N/A
  1. How has study data and documentation been monitored throughout the study? (documented instances of monitoring) Check all that apply.
/ Periodic review and confirmation of participant eligibility
Periodic review of informed consent documentation
Periodic review of the transfer / transcription of data from the original source to the research record
Confirmation that all appropriate information has been reported to the sponsor, oversight agencies (such as the FDA), and/or IRB
Other:
No monitoring has occurred
  1. Who has conducted monitoring of the study data and documentation? Select all that apply.
/ PI
Co-Investigator
Study Staff
Study Monitor/Auditor
Independent Physician, Faculty or Staff Member
Other:
No monitoring has occurred
  1. How often has the study data and documentation been monitored? (documented instances of monitoring)
/ Response:

DELEGATION OF RESPONSIBILITIES

The Principal Investigator has ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human participants, and strict adherence to the study protocol and any stipulations imposed by the University of Utah Institutional Review Board. Delegation of responsibility must be made to qualified and trained investigators and study staff.

For a full list of Principal Investigator Responsibilities, visit the IRB website at

Comments
If your answer indicates a problem, a need for clarification, or N/A, describe the problem below:
  1. Who prepares the IRB applications and documents?
/ PI
Co-Investigator
Study Staff
Other:
  1. Who assesses unanticipated problems and deviations?
/ PI
Co-Investigator
Study Staff
Other:
  1. Who conducts the informed consent process?
/ PI
Co-Investigator
Study Staff
Other:
  1. Who assesses participant eligibility?
/ PI
Co-Investigator
Study Staff
Other:
  1. Who has access to view participant research data?
/ PI
Co-Investigator
Study Staff
Other:
  1. If the PI has delegated any of the above tasks, is there written documentation that the PI remains actively involved in all aspects of the research?
/ Yes
No
N/A

University of Utah IRB

Version: F2211